Quality and Analytical Manager
The Charlotte Quality Analytical Manager is responsible for ensuring customer product requirements are met effectively and efficiently. Keys to success are mentoring and training chemists and lab technicians on the correct use of lab equipment. The Quality & Analytical manager is hands on in conducting tests in timely manner, personally hands on in reviewing any abnormal results to find the root of the irregularity. Assures consistent quality of production by developing and enforcing good automated manufacturing practice (GAMP) systems; Hands on in validating processes; providing
documentation. Quality Manager has oversight of the plant audit program, management reviews and daily/monthly metrics tracking and necessary corrective and preventative actions (CA/PA) are critical to the role. Position supports 24/7 chemical plant operation on-call.
POSITION IN THE ORGANIZATION
The Quality/Analytical Manager reports to the Plant Manager and directly manages QC Chemists;
Indirect – Supervisors, Operators to ensure quality or contain problems.
TASKS AND RESPONSIBILITIES
- Daily assurance of lab operational capability, on-going equipment PM and calibration programs to support analysts and operator testing
- Organize training for quality assurance staff to enhance their skill and knowledge of product quality requirements
- Hands on in developing methodologies and their validation specifically by HPLC/MS
- Setting and implementing internal/external quality requirements to ensure company products/services meet customer expectations
- Conduct assessment of company production processes to develop in -house quality policies, procedures and specifications
- Carry out research to identify ways to reduce and maximize resources
- Collect, compile, and analyze relevant quality statistical data to obtain information regarding quality performance
- Review existing process, instrumentation and product specification to identify the need for improvement or upgrade
- Daily and forward-looking evaluation of product quality status and actions taken to prevent, resolve or contain product quality issues
- Immediate understanding, communication and resolution of issues arising from above production and suppliers
- Responsible fiscal stewardship of QC Lab budget, input to plant commercial decisions and aggressive rework recovery
- Configuration and maintenance of lab information systems including formula/specification review and implementation
- Site Leader of CAPA and CCA processes, customer audits and ISO management system representative
- Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures
- Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
- Using comprehensive and punctual quality metrics tracking, analysis and reporting, a driver for continuous improvement of the plant processes.
- Directs resources and coordinates peer activities to quickly understand, contain, correct and solve product quality problems
- Conduct tests to verify the quality of raw materials and finished products
- Demonstrates positive can-do attitude, listen to employee feedback and provide assistance to allow all site employees to perform safe and effective
- Analyze data to identify areas for improvement in the quality system
- May perform other duties as required
- All other possible occurring tasks or responsibilities;
- Work in accordance with company rules and regulations;
Replaces by absence:
- Production team members
- R & D team members
- Executive team members
- Quality Control
- Supply Chain
- Product Manager
- External Auditors
Education and experience
- Minimum BS in Chemistry
- Or related Science with 5-10 years of hands-on experience in Manufacturing/Quality Control in Chemical processing industry Specific experience (IT etc)
- Direct Experience in developing methodologies and their validation specifically by HPLC/MS
- Certified Quality Engineer, Quality Auditor or Six Sigma Training a plus.
- Business Management, Financial training and Negotiations skills training recommended.
- Strong computer skills including Microsoft Office, QA applications and databases
- Knowledge of tools, concepts and methodologies of QA
- Knowledge of relevant regulatory requirements
IGM Resins offers a very diverse and challenging role, in a highly dynamic and global organization. In addition to that we offer you an attractive salary and other employee benefits, as well as good career opportunities.
To submit your resume or for more information about this vacancy, please contact our Human Resource department.